NCT03412695

Brief Summary

The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system "MyFood" which can be used to assess patients' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. The investigators will study the clinical effects of using MyFood among hospitalized patients. In addition the implementation of the tool among healthcare workers will be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 22, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

January 10, 2018

Last Update Submit

July 30, 2019

Conditions

Malnutrition

Keywords

Disease-related malnutritioneHealthDecision support systemClinical nutrition

Outcome Measures

Primary Outcomes (1)

  • Change in body weight (kg) during hospital stay

    Measured standing on an electronic scale

    2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)

Secondary Outcomes (7)

  • Patient length of hospital stay

    At the day of patient discharge (on day 11)

  • Change in body Composition

    2 times each week, from patient admission (day 1) to hospital discharge (on average day 11)

  • Proportion of patients who receives a nutrition diagnose

    Assessed from medical journals every second day during each patient's hospital stay (11 days on average)

  • Proportion of patients who get implemented nutrition-related measures

    Assessed from medical journals every second day during each patient's hospital stay (11 days on average)

  • Proportion of patients who receive a nutrition plan

    Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average)

  • +2 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Use of the MyFood tool among patients and nurses (intervention group)

Device: MyFood

Arm B

NO INTERVENTION

No intervention. Regular hospital routines

Interventions

MyFoodDEVICE

Patients included in the intervention group will use the MyFood app to record their dietary intake. Nurses will use the report and recommendations in the MyFood tool to follow up the nutritional treatment of the patients.

Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \<72 hours expected hospital stay
  • Terminal patients
  • Pregnant
  • Psychiatric patients
  • Patients who cannot read the Norwegian Language
  • Patients diagnosed with: sickle cell anemia, haemophilia, or deep vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university hospital, Rikshospitalet

Oslo, 0372, Norway

Location

Related Publications (2)

  • Paulsen MM, Varsi C, Andersen LF. Process evaluation of the implementation of a decision support system to prevent and treat disease-related malnutrition in a hospital setting. BMC Health Serv Res. 2021 Mar 25;21(1):281. doi: 10.1186/s12913-021-06236-3.

    PMID: 33766017DERIVED

  • Paulsen MM, Paur I, Gjestland J, Henriksen C, Varsi C, Tangvik RJ, Andersen LF. Effects of using the MyFood decision support system on hospitalized patients' nutritional status and treatment: A randomized controlled trial. Clin Nutr. 2020 Dec;39(12):3607-3617. doi: 10.1016/j.clnu.2020.03.012. Epub 2020 Mar 19.

    PMID: 32241711DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project coordinator

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 26, 2018

Study Start

August 22, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)